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The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction

Primary Purpose

Point-of-care Ultrasound, Distal Radius Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Point-of-care ultrasound
Closed fracture reduction
Sponsored by
Marcus Van Aarsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Point-of-care Ultrasound, Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • radiographically confirmed distal radius fracture

Exclusion Criteria:

  • patients who do not consent
  • patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion)
  • patients with neurovascular compromise
  • patients with bilateral distal radius fractures
  • patients with minimally displaced distal radius fractures that do not require closed reduction before casting

Sites / Locations

  • St. Joseph's Health Care LondonRecruiting
  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Experimental Group

Arm Description

Patients will undergo standard closed fracture reduction. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. Point-of-care ultrasound will not be used.

Patients will undergo standard closed fracture reduction with the addition of point-of-care ultrasound use to assess post-reduction dorsal angulation. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Residual dorsal angulation

Secondary Outcome Measures

Need for orthopaedic surgery within 6 weeks of injury
To be acquired via electronic patient charting
Physician satisfaction: post-reduction questionnaire

Full Information

First Posted
November 2, 2016
Last Updated
June 20, 2018
Sponsor
Marcus Van Aarsen
Collaborators
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02962206
Brief Title
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Official Title
The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcus Van Aarsen
Collaborators
Lawson Health Research Institute

4. Oversight

5. Study Description

Brief Summary
Distal radius (Colle's) fractures in adult patients are commonly reduced in the emergency department before casting. Standard of care currently requires that x-rays be performed before and after fracture reduction, and inadequate reductions may be subject to repeat attempts and are at a higher risk to require surgery. This study will assess the use of point-of-care ultrasound (POCUS) in addition to standard care as a tool to decrease the angulation at the fracture site after a reduction is performed. If this angulation is decreased, it would suggest that POCUS for distal radius fracture reduction could decrease the number of failed reduction attempts and therefore the number of repeated reduction attempts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Point-of-care Ultrasound, Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Patients will undergo standard closed fracture reduction. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician. Point-of-care ultrasound will not be used.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients will undergo standard closed fracture reduction with the addition of point-of-care ultrasound use to assess post-reduction dorsal angulation. The sedation type, reduction method, and immobilization method will be at the discretion of the treating physician.
Intervention Type
Device
Intervention Name(s)
Point-of-care ultrasound
Other Intervention Name(s)
POCUS
Intervention Description
After the fracture reduction maneouver, the physician will assess residual dorsal angulation using point-of-care ultrasound. If deemed adequate, the physician will progress to immobilization. If the reduction is not adequate, the physician will attempt further reduction at their discretion.
Intervention Type
Procedure
Intervention Name(s)
Closed fracture reduction
Intervention Description
The distal radius fracture will be reduced with using a combination of local anesthetic, sedation, reduction maneouvers and immobiliazation at the discretion of the treating physician
Primary Outcome Measure Information:
Title
Residual dorsal angulation
Time Frame
Collected at the same-day post-reduction xray. Data will be aggregated over 1 year
Secondary Outcome Measure Information:
Title
Need for orthopaedic surgery within 6 weeks of injury
Description
To be acquired via electronic patient charting
Time Frame
To be assessed 6 weeks post-injury. Data will be aggregated over the 1 year study period
Title
Physician satisfaction: post-reduction questionnaire
Time Frame
Questionnaire to be administered immediately after reduction. Data to be aggregated during the 1 year study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: radiographically confirmed distal radius fracture Exclusion Criteria: patients who do not consent patients with multiple acute injuries, open fractures, or other local fractures evident (a simple ulnar styloid fracture will not be considered an exclusion criterion) patients with neurovascular compromise patients with bilateral distal radius fractures patients with minimally displaced distal radius fractures that do not require closed reduction before casting
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine P Van Aarsen, MSc
Phone
519-685-8500
Ext
76089
Email
kristine.vanaarsen@lhsc.on.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine P Van Aarsen, MSc
Phone
519-685-8500
Ext
76089
Email
kristine.vanaarsen@lhsc.on.ca

12. IPD Sharing Statement

Learn more about this trial

The Effect of Point-of-care Ultrasound Guidance for Distal Radius Fracture Reduction

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